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T-1249 how can we help bring this product to faster approval in US?
Aug 1, 2003

Dr. Young,

I have heard that t-1249, t-20's cousin is more potent in clinical trials? I was wondering what have you heard about this compound and also how can we help in bringing this hiv product to approval faster. And Dr. Young, this is for all the positive patients, take notes what this kind doctor says and do the work necessary to bring this product to approval. Doctor Young, thanks a million. I hope you get a nice bonus.

Samantha :-)

Response from Dr. Young

T-1249 is the second fusion inhibitor from Roche-- the follow up to enfuvirtide. Very promising potency and resistance properties have been shown in clinical trials (see our conference coverage for more details).

Your question about how to bring this product to approval faster is interesting, but difficult to answer (this applies to all investigational compounds). Drug discovery requires multiple steps and high levels of independent scrutiny. Clinical trials take years to design, enroll, execute and analyze. As such, other than making sure that drug companies are motivated to having the program mature as quickly as possible (believe me, there is considerable financial pressure to do so), much has to do with how quickly studies are enrolled-- often the slow and variable step in clinical trials. So, my soapbox says that from the public's point of view, encourage participation in clinical trials (when appropriate), make sure that the clinical trials are well designed and ask (or answer) relevant clinical issues.

Lastly, because of the incredible cost of drug discovery (about $500 million per new drug), we are in the dilema of wanting new drugs but wanting drugs to be inexpensive. This is a difficult balance to strike, but from the limited view of wanting new drugs, the push to lower and lower prices (or off patent generics) is, in my view, a disincentive to the developement of new drugs. BY



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